In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a ()-Sodium L-ascorbate Drug Master File in Korea (()-Sodium L-ascorbate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ()-Sodium L-ascorbate. The MFDS reviews the ()-Sodium L-ascorbate KDMF as part of the drug registration process and uses the information provided in the ()-Sodium L-ascorbate KDMF to evaluate the safety and efficacy of the drug.
After submitting a ()-Sodium L-ascorbate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their ()-Sodium L-ascorbate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ()-Sodium L-ascorbate suppliers with KDMF on PharmaCompass.